510(k) · Cleared
Recalled · 2004Sure Check Pregnancy Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chembio Diagnostic Systems, Inc. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Jun 24, 1996 as substantially equivalent to K923925 (Chembio Diagnostic Systems, Inc., 1992) after a 35-day review. Its family tree reaches back 1 generation to 1992. It has been recalled once.
- Decided
- Jun 24, 1996
- Review
- 35 days
- Class
- Class II
- Product code
- LCX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923925 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK923925 HCG Stat-PakChembio Diagnostic Systems, Inc. · 1992
- This deviceK961965 Sure Check Pregnancy TestChembio Diagnostic Systems, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923925 | HCG Stat-Pak | Chembio Diagnostic Systems, Inc. | 1992 | — |
| 0 (this device) | K961965 | Sure Check Pregnancy Test | Chembio Diagnostic Systems, Inc. | 1996 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LCX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LCX device
- #1 K251040 MissLan® Early Detection Digital Pregnancy…score 11.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K923925 | HCG Stat-PakSummary page 1…ic Systems, Inc. 3661 Horseblock Road Medford, NY 11763 Date Summary Prepared: May 14, 1996 2. Name of the Device: Sure Check™ Pregnancy Test Chembio HCG STAT-PAK, K#923925/A Clearblue Easy Pregnancy Test, E.P.T. Pregnancy Test The Sure Check™ Pregnancy Test is a self contained immunochromatographic… | 1992 |
| * | — | Clearblue Easy Pregnancy Test Named without a submission number | |
| * | — | E.P.T. Pregnancy Test Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 6, 2004 | Not classified | Z-0276-05 | Other | Poor sealing of pouches and degradation of products. Firm received an e-mail from a distributor of an increase in complaints. In response to the complaints, the distributor conducted its own functional testing and noticed a degradation in… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All LCX devicesLCX Kit, Test, Pregnancy, Hcg, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LCX
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LCX
102in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LCX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCX
6in 2025
MAUDE reports naming product code LCX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 223 | 0 | 26 |
| 2008 | 0 | — | 0 | 45 |
| 2009 | 2 | — | 1 | 8 |
| 2010 | 0 | — | 2 | 21 |
| 2011 | 5 | 234 | 0 | 19 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 8 | 152 | 0 | 3 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 4 | 162 | 0 | 2 |
| 2019 | 7 | 50 | 0 | 3 |
| 2020 | 2 | — | 0 | 3 |
| 2021 | 2 | — | 0 | 4 |
| 2022 | 6 | 264 | 0 | 12 |
| 2023 | 2 | — | 8 | 6 |
| 2024 | 10 | 132 | 0 | 3 |
| 2025 | 5 | 102 | 1 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
An OTC hCG Pregnancy Test for home use intended for the early detection of pregnancy. It is intended to measure hCG, a placental hormone, in urine sample.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961965 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961965: Sure Check Pregnancy Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961965
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026